Associate Scientist

"All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment".

Job Title: Associate Scientist

Location: Summit, NJ

Duration: 06 Months

Pay rate: 48.95/hr on w2

100% onsite

Work Schedule: M-F- (9am - 5pm) EST

Bachelor's degree required

Duration: 6 months (possibility of extension for right candidate depending on performance)

Purpose And Scope Of Position:

• The Associate Scientist/Engineer is responsible for leading investigation reports in support.
• T operations. This includes execution of thorough root cause investigations, interviewing personnel,
• hypothesis testing and interpretation of results, authoring investigation reports, identifying corrective and
• preventive actions (CAPA), and troubleshooting complex problems. The successful incumbent must
• interface closely with different functional organizations, including Quality Assurance teams.

Required Competencies:

Knowledge, Skills, and Abilities:

• Working experience of deviation investigations utilizing root cause analysis tools.
• Working experience in the CAPA process and ability to identify and verify effectiveness.
• Technical writing skills and ability to collaborate effectively in cross functional teams.
• Proven ability to accurately and completely understand, follow, interpret, apply Global Regulatory and cGMP requirements.
• Ability to support health authority inspections.
• Knowledge of data trending and tracking, including use of statistical analysis software a plus.
• Demonstrate advanced problem-solving ability / mentality, technical adeptness and logical thinking.
• Ability to set priorities, manage timelines and effectively react/manage changing priorities.
• Ability to work with management (global and site) and support corporate and departmental goals.
• Ability to communicate honestly, transparently and effectively with peers, department management and cross functional peers.
• Ability to utilize electronic Quality systems such as eQRMs (Enterprise Quality and Regulatory
• Management system) or Infinity.
• Hands on experience preferred with CAR-T or biopharmaceutical manufacturing and Quality Control.

Education and Experience:

• Requires a Bachelors Degree in science or engineering, preferably in Biochemistry, life sciences or related engineering discipline (advanced degree preferred).
• Minimum 1 year of relevant work experience, preferably in a health authority regulated environment.
• Previous experience working in a biopharmaceutical manufacturing facility is preferred (CAR T a plus).
• An equivalent combination of education and experience may substitute.

Duties And Responsibilities:

• Conduct thorough investigations (Environmental Monitoring, deviations, etc.) utilizing root cause analysis tools.
• Lead investigations and cross functional investigation teams, and close reports in a timely manner
• Perform GEMBA walks with stakeholders to better understand process steps and evaluate
• Root Cause Analysis.
• Work with functional teams to propose effective CAPAs, develop CAPA plans and assure
• CAPA effectiveness.
• Assess potential impact and risk to product or process associated changes may have upon change implementation and develop an appropriate mitigation strategy.
• May Initiate change control documentation
• Identify functional area SMEs to perform impact assessments as part of the change management process.
• Ensure all investigations are completed in a timely manner. Notify stakeholders of any delays in a timely manner.
• Provide technical support for manufacturing investigations / CAPAs / change controls as needed.
• Support deviation investigation defense during audits and site inspections related inquiries.
• Handle complex issues and solve problems with minimal guidance.
• Serve as author or technical reviewer of departmental procedures as appropriate.
• Employ lean manufacturing / six sigma principles to continuously improve products, processes and systems.
• Continuously support S12, living the ?patients first? mission and fostering a ?Right First Time? mindset.

Working Conditions (US Only):

• The incumbent will be working 80% to 90% of the time in an office environment.
• The incumbent will be working 10% to 20% of the time in a manufacturing and/or laboratory setting.
• The incumbent may travel between NJ sites for training, meetings or corporate events on occasion.
• The incumbent will need to have flexibility to work extended hours (>8 hours/day),
• weekend and/or holidays when required to meet deadlines.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.